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Exela Pharma Sciences LLC FDA Recalls
10 recalls on file across drugs, 7 of them Class I and 5 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx OClass IIJul 30, 2025Failed Impurities/Degradation Specifications: out of specifi |
| 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For IntravenouClass IIMar 7, 2025Lack of Assurance of Sterility |
| Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to UClass IOct 18, 2023Presence of Particulate Matter: Silicone |
| ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For IntravenoClass IOct 18, 2023Presence of Particulate Matter: Silicone |
| 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; CaClass IOct 18, 2023Presence of Particulate Matter: Silicone |
| 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials,Class INov 28, 2022Defective Container: Complaints received of vial breakage an |
| 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials,Class INov 28, 2022Defective Container: Complaints received of vial breakage an |
| 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials,Class IOct 4, 2022Defective Container: Complaints received of vial breakage an |
| 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials,Class IOct 4, 2022Defective Container: Complaints received of vial breakage an |
| 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: EClass IIJan 11, 2022Lack of Assurance of Sterility |